(26 days)
Not Found
No
The document explicitly states that the device "does not perform any diagnosis of data by itself" and only displays calculated values and graphs. There is no mention of AI, ML, or related terms in the description or the "Mentions AI, DNN, or ML" section.
No
The device is a software package for data analysis and reporting from Holter recordings, not for direct treatment or therapy. It displays ECG morphologies and calculated graphs for physician review, but does not perform diagnosis or therapeutic functions itself.
No
The device is described as a software package that allows a physician to download, analyze, review, and produce reports from long-term continuous ECG recordings. However, the text explicitly states, "CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs." This indicates it is a tool for data presentation and analysis, not a diagnostic device that renders a diagnosis.
Yes
The device is described as a "software package" delivered on a CD, and its function is to download, analyze, review, and produce reports from data collected by a separate digital flash memory Holter recorder. It does not include the hardware recorder itself.
Based on the provided information, this device is NOT an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that CardioDay® analyzes electrocardiographic (ECG) recordings, which are electrical signals measured from the body's surface, not specimens like blood, urine, or tissue.
- The device processes electrical signals, not biological samples. The input modality is ECG recording, which is a measurement of electrical activity, not a biological sample.
- The device's function is to display and analyze ECG data. It does not perform tests on biological specimens to diagnose diseases or conditions.
The device is a software package for analyzing physiological data (ECG) collected from a patient, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CardioDay" is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.
This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.
Federal law restricts CardioDay® to use on order of a physician.
CardioDay is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.
WARNING:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.
Product codes
DQK
Device Description
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician or health care professional knowledgeable in Holter interpretation / Not intended for any ambulatory or home applications.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The impact of all parameters, especially those specified above, is evaluated with the help of the data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) and performance evaluations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
JUN 29 2005
| 510(k) Notification | getemed |
|---|---|
| CardioDay® | Project ID: 0429S1 |
| 510(k) - Summary | Section 1-0001-Rev D |
1 510(k) - Summary
| Submitted By: | getemed Medizin- und Informationstechnik AG
Oderstr. 59
14513 Teltow
Germany
Tel.: +49 3328 - 3942-70
Fax: +49 3328 - 3942-99 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Bert Schadow
Regulatory Affairs Manager |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG
Oderstr. 59
14513 Teltow
Germany |
| Date of Preparation: | 2005-06-13 |
| Trade Name: | CardioDay® |
| Common Name: | Holter ECG |
| Classification Name: | Computer, Diagnostic, Programmable |
| Product Classification: | 21 CFR 870.1425, Class II |
| Product Code: | DQK |
| Legally Marketed Devices: | Holter for Windows® (K930564, Northeast
Monitoring Inc.) |
Reason for Submission
Premarket notification for CardioDay® (Version 1.9.5), a New Device, seeking authority to market the device under Section 510(k) as a device that is substantially equivalent to the Holter for Windows® evaluation software (K930564, Northeast Monitoring Inc.).
Intended Use
CardioDay" is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.
This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.
Federal law restricts CardioDay® to use on order of a physician.
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY
1
| 510(k) Notification | getemed |
|---|---|
| CardioDay® | Project ID: 0429S1 |
| 510(k) - Summary | Section 1-0001-Rev D |
Indications for Use
CardioDay is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.
WARNING:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.
Device Description
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
| Description | ||
|---|---|---|
| Intended use | Holter for Windows® is Holter | |
| monitoring software, designed to | ||
| perform high-speed data analysis | ||
| of continuous, long-term | ||
| electrocardiograms saved in the | ||
| form of direct recordings on a | ||
| cassette tape or flash memory | ||
| card. Holter for Windows® is | ||
| intended for use as an analysis | ||
| tool and produces printed reports | ||
| to be reviewed by a person | ||
| knowledgeable in Holter | ||
| interpretation. |
Federal law restricts Holter for
Windows® to use on order of a
physician. | CardioDay® is a software package
that allows a trained physician or
health care professional
knowledgeable in Holter
interpretation, after having
performed a long-term continuous
electrocardiographic (ECG)
recording on digital flash memory
Holter recorder, to download and
analyze the data from the recorder,
review it and produce printed
reports.
This device is available only upon
the order of a physician or other
licensed medical professional and
not intended for any ambulatory or
home applications.
Federal law restricts CardioDay® to
use on order of a physician. |
Comparison to Legally Marketed Device
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY
Page 2 of 11
2
| 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Description | Facility's CardioDay® | ||
| Predicate Index | |||
| Indications for use | Same as CardioDay® | CardioDay® is a Holter software | |
| which is indicated for patients who | |||
| may benefit from a long-term | |||
| continuous electrocardiographic | |||
| (ECG) recording, including, but not | |||
| limited to, those with complaints of | |||
| palpitations, syncope, chest pain, | |||
| shortness of breath, or those that | |||
| need to be monitored to judge their | |||
| current cardiac functionality such as | |||
| patients who have recently received | |||
| pacemakers. |
WARNING:
CardioDay® does not perform any
diagnosis of data by itself but only
displays ECG morphologies and
associated, calculated graphs such
as heart rate trends, RR variability,
and other statistical values. | |
| Device description | Same as CardioDay® | CardioDay® does not perform any
diagnosis of data by itself but only
displays ECG morphologies and
associated, calculated graphs such
as heart rate trends, RR variability,
and other statistical values in
graphical form. The physician will be
able to review, edit, and print the
data collected. | |
| Target population | Same as CardioDay® | Patients who may benefit from a
long-term continuous
electrocardiographic (ECG)
recording, including, but not limited
to, those with complaints of
palpitations, syncope, chest pain,
shortness of breath, or those that
need to be monitored to judge their
current cardiac functionality such as
patients who have recently received
pacemakers. | |
| Design / materials | Same as CardioDay® | CardioDay® is a software package
which is delivered on CD. | |
| Sterility | This section does not apply. | This section does not apply. | |
| Biocompatibility | This section does not apply. | This section does not apply. | |
| Mechanical safety | This section does not apply. | This section does not apply. | |
| Chemical safety | This section does not apply. | This section does not apply. | |
| Anatomical sites | This section does not apply. | This section does not apply. | |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
CONFIDENTIAL AND PROPRIETARY
·
Page 3 of 11
ાં ડા
3
| 510(k) Notification | getemed | |
|---|---|---|
| CardioDay® | Project ID: 0429S1 | |
| 510(k) - Summary | Section 1-0001-Rev D | |
| Description | Holter for Windows® | |
| Human factors | Same as CardioDay® | Human factors engineering: |
- device technology (see
comparison of technology
characteristics), - the users (see target
population), - environment in which the
technology will be used (see
intended use), - how dangerous is the use of the
device (see level of concern in
section 2), - how critical is the device for
patient care (see product
classification and level of
concern in section 2). |
| Energy used and/or
delivered | This section does not apply. | This section does not apply. |
| Compatibility with
environment and
other devices | See comparison of technology
characteristics and miscellaneous | See comparison of technology
characteristics and miscellaneous |
| Where used:
hospital, home,
ambulance, etc. | Holter for Windows® is available
for sale only upon the order of a
physician or other related licensed
medical professional. | CardioDay® is available for sale only
upon the order of a physician or
other related licensed medical
professional and not intended for
any home use applications. |
| Electrical safety | This section does not apply. | This section does not apply. |
| Thermal safety | This section does not apply. | This section does not apply. |
| Radiation safety | This section does not apply. | This section does not apply. |
Comparison of Technology Characteristics Compared to Legally Marketed Device:
| Specifications | ||
|---|---|---|
| Type | IBM PC AT compatible | IBM PC AT compatible |
| CPU | Pentium II Processor | Pentium III, 500MHz or greater |
| RAM | 32 Mbytes minimum | 128 Mbytes minimum, |
| 256 Mbytes minimum for XP | ||
| Free hard disk | ||
| space | 200 MB minimum | 5 GB minimum |
| 20 GB for 12-lead recordings | ||
| Display | VGA, 14", 1024 x 768 pixel, 256 | |
| colors | 17" CRT or 15" TFT, 1024 x 768 | |
| pixel (XGA), 256 colors | ||
| Disc drive / floppy | ||
| drive | 1.4 Mbytes | Not required |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
CONFIDENTIAL AND PROPRIETARY
.
4
| 510(k) Notification
| CardioDay® | o getemed | |
|---|---|---|
| Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | |
| Specifications | Hotter for Win | |
| CD-ROM drive | For installation only | For installation only. |
| Needs to be replaced by a CD-ROM | ||
| writer or DVD writer if archive option | ||
| implemented | ||
| Operating system | Windows 98 | Windows 98 SE, NT (SP6a), 2000 |
| or XP | ||
| Ports | One free parallel port | 1 parallel port sufficient; if USB |
| devices used for printing, software | ||
| key or card reader, then | ||
| corresponding USB ports required | ||
| Printer | Printer as any Windows ™ | |
| compatible | Printer as any Windows ™ | |
| compatible, 300 dpi | ||
| Keyboard | Standard device | Standard device |
| Mouse | Standard, 2-button device | Standard, 2 or 3-button device |
| Installation media | (1) CD | (1) CD |
| Further periphery | Compact Flash card reader | CompactFlash (Type I) memory |
| card reader |
Comparison of Software Characteristics:
| Patient Screen | FORM DESIGNATION
Section Windows | |
|-------------------------------------------------------------|-------------------------------------|-----|
| Patient Identification Number | Yes | Yes |
| Patient Name, Address, Telephone | Yes | Yes |
| Patient Personal Data (Age, Gender, Date of Birth,
etc.) | Yes | Yes |
| Medication | Yes | Yes |
| Indication | Yes | Yes |
| Physician's Name | Yes | Yes |
| Date of Recording | Yes | Yes |
| Analysis Options | ||
|---|---|---|
| Analysis Duration | Yes | Yes |
| Primary Channel Selection | Yes | Yes |
| Sensitivity / Signal Quality | Yes | Yes |
| Tachycardia Threshold [bpm] | Yes | Yes |
| Bradycardia Threshold [bpm] | Yes | Yes |
| Pause Duration [ms] | Yes | Yes |
| SV Prematurity [%] | Yes | Yes |
| V Prematurity [%] | Yes | Yes |
| R on T [ms] | Yes | Yes |
| Pacemaker Type | Yes | Yes |
| Minimum Pulse Rate [bpm] | Yes | Yes |
| Maximum Pulse Rate [bpm] | Yes | Yes |
| Superimposition / QuickScan | Yes | Yes |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
CONFIDENTIAL AND PROPRIETARY
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长0.51471/51
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5
| 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Analysis Options | Holter for Windows | New Device | |
| CardioDay | |||
| 12-Lead ECG Module | Yes | Yes | |
| Holter Data Transfer | Yes | Yes | |
| Events Detected | Holter for Windows | New Device | |
| CardioDay | |||
| Burst | Yes | Yes | |
| VES / VPB (Extrasystole) | Yes | Yes | |
| SVES / SVPB (Supraventricular Extrasystole) | Yes | Yes | |
| Couplet / VPB Pair | Yes | Yes | |
| Triplet | Yes | Yes | |
| VTACH / VTAC (Ventricular Tachycardia) | Yes | Yes | |
| Bigeminy | Yes | Yes | |
| R on T | Yes | Yes | |
| ST-Analysis | Yes | Yes | |
| SVTACH / SVT (Supraventricular Tachycardia) | Yes | Yes | |
| Arrhythmia / Irregular R-R | Yes | Yes | |
| Bradycardia | Yes | Yes | |
| VTACH (with 4 Beats) / Burst | Yes | Yes | |
| V. STIM / V. Paced | Yes | Yes | |
| A. STIM / A. Paced | Yes | Yes | |
| AV. STIM / AV Paced | Yes | Yes | |
| Undersense / Sense Failure | Yes | Yes | |
| Exitblock / Capture Failure | Yes | Yes | |
| Oversense / Inhibition | Yes | Yes | |
| Pause / Arrest | Yes | Yes | |
| Event Marker | Yes | Yes | |
| HR Stripes | Yes | Yes | |
| Artifact | Yes | Yes | |
| Normal | Yes | Yes |
| Functionality Available | ||
|---|---|---|
| The comparison between the legally marketed de- | ||
| vice and the NEW DEVICE is based on their func- | ||
| tions only and not on their names. | ||
| Start | Yes | Yes |
| Read Tape | Yes | Yes |
| Read Digital Recorder | Yes | Yes |
| Import | Yes | Yes |
| Analyze New | Yes | Yes |
| Open | Yes | Yes |
| Edit Patient Data | Yes | Yes |
| Print Preview | Yes | Yes |
| Yes | Yes | |
| Close Recording | Yes | Yes |
| Close | Yes | Yes |
0429S1-Sec01-0001-RevD-CardioDay-Execulive_Summary.doc
CONFIDENTIAL AND PROPRIETARY
Page 6 of 11
6
| 510(k) Notification | o getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Functionality Available | Legally Marketed Device | ||
| Holter for Windows | Predicate Device | ||
| CardioDay | |||
| Delete Recording | Yes | Yes | |
| Archive | Yes | Yes | |
| Diagnosis | Yes | Yes | |
| View ECG | Yes | Yes | |
| Print Preview | Yes | Yes | |
| Screen Scale Calibration | Yes | Yes | |
| Screen: Colour Setup | Yes | Yes | |
| FFT Setup | Yes | Yes | |
| Report Setup | Yes | Yes | |
| Classes Display | Yes | Yes | |
| PM Events Display | Yes | Yes | |
| Events Display | Yes | Yes | |
| HR Min./Max. Display | Yes | Yes | |
| Statistics Display | Yes | Yes | |
| Diagnosis Display | Yes | Yes | |
| Overview Display | Yes | Yes | |
| Context sensitive Help | Yes | Yes | |
| Keyboard Shortcuts Help | Yes | Yes | |
| Menu Entries Help | Yes | Yes | |
| Help: About | Yes | Yes | |
| Help: Version | Yes | Yes | |
| Icons/Buttons Available | Legally Marketed Device (Hotar or Window) | NEW DEVICE (Display) | |
| The following comparison between the legally | |||
| marketed device and the NEW DEVICE is based on | |||
| their functions only. The label and form of the icons | |||
| / buttons, however, are different. It might even take | |||
| more than one click to initiate a given action. | |||
| Start: Read Digital Recorder | Yes | Yes | |
| Start: Read Tape Recorder | Yes | Yes | |
| Start: Open Existing Record | Yes | Yes | |
| Digital Recorder | Yes | Yes | |
| Tape Recorder | Yes | Yes | |
| Open: List of Patients | Yes | Yes | |
| Yes | Yes | ||
| Rhythm Analysis | Yes | Yes | |
| Print Preview on Screen | Yes | Yes | |
| Options Available | Legally Marketed Device (Note on Wind) | New Device (Note on Wind) | |
| The following comparison between the legally mar- | |||
| keted device and the NEW DEVICE is based on their | |||
| functions only. The name of those options may vary. | |||
| Classes | Yes | Yes | |
| Events | Yes | Yes | |
| Heart Rate Min/Max | Yes | Yes |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
CONFIDENTIAL AND PROPRIETARY
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7
| 510(k) Notification | getemed | |
|---|---|---|
| CardioDay® | Project ID: 0429S1 | |
| 510(k) - Summary | Section 1-0001-Rev D | |
| Options Available | Legally Marketed Device Holter for Windows | New Device CardioDay |
| Average Heart Rate | Yes | Yes |
| Statistics: FFT Analysis | Yes | Yes |
| Statistics: ST Diagrams | Yes | Yes |
| Report | Yes | Yes |
| Overview | Yes | Yes |
| Heart Variability: RR Delay | Yes | Yes |
| Heart Rate Variability: RR FFT | Yes | Yes |
| Heart Rate Variability: 24h RR FFT | Yes | Yes |
| Heart Rate Variability: RR Histograms | Yes | Yes |
| Graphics & Displays Available | Legally Marketed Device: | |
| Holter for Windows | New Device: | |
| CardioDay | ||
| The following comparison between the legally mar- | ||
| keted device and the NEW DEVICE is based on their | ||
| functions only. The label and appearance of those | ||
| displays may vary. | ||
| Classified Beats Grouped into Morphology Bins | Yes | Yes |
| Zoomed Version of Selected Beat | Yes | Yes |
| Context of Selected Beat | Yes | Yes |
| Events | Yes | Yes |
| Heart Rate Trend in Recording Period | Yes | Yes |
| Average RR Interval | Yes | Yes |
| Y-T Distribution | Yes | Yes |
| RR > 50ms Distribution | Yes | Yes |
| FFT Analysis | Yes | Yes |
| ST Diagrams | Yes | Yes |
| Overview 2 channels at Different Scaling Factors | Yes | Yes |
| Printout Options | Legally Marketed Device | |
| Hoferator Window | New Device | |
| CardioDay | ||
| The following comparison between the legally mar- | ||
| keted device and the NEW DEVICE is based on their | ||
| functionality only. The commands to generate a | ||
| given printout as well as its appearance do vary. | ||
| Full Disclosure 2 Channels, 1 h/Page | Yes | Yes |
| Full Disclosure 2 Channels, 15 min./Page | No | Yes |
| Full Disclosure 2 Channels, 30 min./Page | Yes | Yes |
| Marked Events: 8 Events/Page | Yes | Yes |
| Marked Events: 32 Events/Page | Yes | Yes |
| Marked Events: Analysis Channel 25 mm/s | Yes | Yes |
| Marked Events: Analysis Channel 2.5 min + | ||
| 25mm/s | No | Yes |
| Selected Channels 25 mm/s | Yes | Yes |
| Selected Channels 1 min. + 25 mm/s | Yes | Yes |
| Selected Channels 2.5 min. + 25 mm/s | No | Yes |
| Selected Channels 10 min. + 25 mm/s | No | Yes |
| Event Table | Yes | Yes |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
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051471/51
가이디
8
| 510(k) Notification | getemed | |
|---|---|---|
| CardioDay® | Project ID: 0429S1 | |
| 510(k) - Summary | Section 1-0001-Rev D | |
| Printout Options | Legally Marketed Device Holter for Window | New Device CardioDay |
| Event Histogram | Yes | Yes |
| Heart Rate and ST Diagrams | Yes | Yes |
| HR diagram + Min/Max per Minute | No | Yes |
| RR Intervals | Yes | Yes |
| RR Delay | No | Yes |
| RR Histograms | No | Yes |
| RR Interval Spectra | No | Yes |
| Pacemaker Event Histogram | Yes | Yes |
| Pacemaker Function Analysis | Yes | Yes |
| Report | Yes | Yes |
| Print to File (PDF) | Yes | Yes |
| Save as Default Option | Yes | Yes |
| Editing & Reviewing Options | Legally Marketed Device to Windows | New Device CardioDay |
| The following comparison between the legally mar- keted device and the NEW DEVICE is based on their functions only. The label and appearance of those options may vary. | ||
| Scroll through all Beats in a Morphology Bin | Yes | Yes |
| Edit all Beat Labels in a Morphology Bin | No | Yes |
| Scroll through ECG and Edit Single Beat Labels | No | Yes |
| Scroll through Events of the Same Type | Yes | Yes |
| Edit Event Marker | Yes | Yes |
| View Patient Event Markers | Yes | Yes |
| Jump from any Statistics Diagram to the corresponding ECG | No | Yes |
| Jump from ECG Overview to the corresponding ECG | Yes | Yes |
| Select Tme Interval for Time Domain RR Parameters | Yes | Yes |
| Edit Report | Yes | Yes |
| Miscellaneous | Legally Marketed Device Holter for Windows | New Device Cardiology |
| RZ153+ Digital Recorder Supported (K022540) | Yes | Yes |
| CardioMem® CM 3000 (SMA) Supported | Yes | Yes |
| CardioMem® CM 3000-12 Supported | No | Yes |
| CD Installation Medium | Yes | Yes |
| RZ151 Analog Recorder Supported | No | No |
| CD Installation Medium | Yes | Yes |
Standards Comparison
| Standard | Device Master Record
Device History Record | CardioDay |
|------------------------------------------------------|-----------------------------------------------|-----------|
| 21 CFR 820 (FDA cGMP Good Manufacturing
Practice) | Yes | Yes |
042951-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
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1/5/
4/
9
| 510(k) Notification | o getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Standard | Comply Marked Device | ||
| Holter for Windows | Non-Device (C-Code Only) | ||
| ISO 9001:2000 / EN 46001 / ISO 13485:2003 | |||
| Quality Management Systems | Yes | Yes | |
| IEC 60601-1-4 + A1 Programmable Electrical | |||
| Medical Systems | Yes | Yes | |
| ANSI/AAMI EC38 Ambulatory Electrocardiographs | Yes | Yes | |
| IEC 60601-2-47 Particular Requirements for the | |||
| Safety, including Essential Performance, of | |||
| Ambulatory Electrocardiographic Systems | Yes | Yes | |
| ISO 14971 +A1 Application of the Risk | |||
| Management to Medical Devices | Yes | Yes | |
| EN 980 Graphic Symbols for the Marking of | |||
| Medical Devices | Yes | Yes | |
| EN 1041 Supply of Information by the Manufacturer | |||
| of a Medical Device | Yes | Yes | |
| ISO 15223 + AMD1 + AMD2 Symbols to be Used | |||
| with Medical Devices | Yes | Yes |
Differences between the Legally Marketed Device (Holter for Windows®) and the New Device (CardioDay®):
Where Used: Hospital, Home, Ambulance, etc.:
CardioDay® clearly excludes home use applications. This has no influence on safety and effectiveness.
Performance
CardioDay and Holter for Windows® have the following different technology specifications:
| Specifications | Legally Marketed Device
Hot for Windows | New Device
OrtotoBay |
|---------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| CPU | Pentium II Processor | Pentium III, 500MHz or greater |
| RAM | 32 Mbytes minimum | 128 Mbytes minimum,
256 Mbytes minimum for XP |
| Free hard disk space | 200 MB minimum | 5 GB minimum
20 GB for 12-lead recordings |
| Display | VGA, 14", 1024 x 768 pixel,
256 colors | 17" CRT or 15" TFT, 1024 x 768 pixel
(XGA), 256 colors |
| Disc drive / floppy drive | 1.4 Mbytes | Not required |
| CD-ROM drive | For installation only | For installation only.
Needs to be replaced by a CD-ROM
writer or DVD writer if archive option
implemented |
| Operating system | Windows 98 | Windows 98 SE, NT (SP6a), 2000 or XP |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
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K051471/SI
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| 510(k) Notification | getemed | |
|---|---|---|
| CardioDay® | Project ID: 0429S1 | |
| 510(k) - Summary | Section 1-0001-Rev D | |
| Ports | One free parallel port | 1 parallel port sufficient; if USB devices |
| used for printing, software key or card | ||
| reader, then corresponding USB ports | ||
| required |
The minimum hardware requirements, such as CPU, RAM, free Hard disk space, display, CD-ROM drive and ports and supported operating system of CardioDay® correspond to the current state of the art. No influence on safety and effectiveness is expected.
Software characteristics
The new device CardioDay offers a number of editing and printing options not available in the legally marketed device. No influence on safety and effectiveness is expected.
Miscellaneous
Holter for Windows® does not support the Holter recorder CardioMem® CM 3000-12. No influence on safety and effectiveness is expected.
CardioDay® does not support the RZ 151 analog tape recorder. This technology is no longer state of the art and therefore it is not supported. No influence on safety and effectiveness is expected.
Conclusion
CardioDay and Holter for Windows® software packages are both used in clinical applications to allow trained physicians or other health care providers to download, review and print electrocardiographic (ECG) data recorded on digital Holter recorders. Both are computerized programs which run under a computer operating system. Both perform a high-speed analysis of the recorded ECG data and use the computer operating system to access the displayed data. CardioDay® has the same analysis modes as Holter for Windows®. The impact of all parameters, especially those specified above, is evaluated with the help of the data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) and performance evaluations.
WARNING:
CardioDay' does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends. RR variability, and other statistical values.
CardioDay conforms to Good Manufacturing Procedures outlined by the FDA GMP. This software is safe and effective for the application for which it is intended and has been tested to confirm the safety and efficacy of the software. CardioDay® is found to be substantially equivalent to the Holter for Windows® software.
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY
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Image /page/11/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A."
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
getemed Medizin-und Informationstechnik AG c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road Newtown, CT 06470
Re: K051471 Trade Name: CardioDay® Regulation Number: 21 CFR 870.1425 Regulation Name: Diagnostic Programmable Computer Regulatory Class: Class II (two) Product Code: DOK Dated: June 16, 2005 Received: June 17, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Tamas Borsai
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295_ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Blummer for
R. D. Zuber, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
CardioDay® Device Name:
Indications For Use:
CardioDay® is a Holter Software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.
WARNING:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blommima
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
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